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Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa

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Trial Profile

Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs LAMB3 encoding stem cell therapy (Primary)
  • Indications Epidermolysis bullosa
  • Focus Registrational; Therapeutic Use
  • Acronyms Hologene 5
  • Sponsors Holostem Terapie Avanzate
  • Most Recent Events

    • 20 Feb 2022 Status changed from not yet recruiting to recruiting.
    • 15 Feb 2022 Planned End Date changed from 1 Jun 2023 to 1 Jun 2024.
    • 15 Feb 2022 Planned primary completion date changed from 1 Jun 2023 to 1 Jun 2024.

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